The 10 essential activities of the quality assurance unit.

It is certainly my pleasure to be here today. Several months ago, Pat Pomerleau invited me to be on your program. At the time, I had no idea that I would be speaking as Paul Lepore, private citizen, rather than Paul Lepore, regulator and bureaucrat. However, the Food and Drug Administration (FDA) made me an offer I could not refuse and, upon considerable thought, I retired effective September 30, 1994. Immediately, I called Pat for advice on how to deal with my planned presentation before you. Graciously, she said that she did not believe that I would forget all I knew about Good Laboratory Practice (GLP) over 1 weekend and that the Society would love to have me anyway. Today, I intend to discuss the 10 essential activities of a properly functioning quality assurance Unit (GAU). I will summarize the importance of records and documentation to the unit and I will close with some comments on achieving regulatory compliance. My remarks are intended to emphasize that an effective, active quality assurance unit is crucial for ensuring data quality, and that attention paid to day-to-day quality assurance activities will foster regulatory compliance.